XBiotech Data Shows Effective Anti-Virus Activity for True Human Antibodies in Its Candidate Influenza-COVID-19 Therapeutic Cocktail

Rhea-AI Summary

XBiotech Inc. (NASDAQ: XBIT) announced promising new data regarding its FLUVID™ therapy for treating co-infections of influenza and COVID-19. The therapy's antibodies neutralize test viruses four times more effectively than those under FDA consideration for emergency use. Research indicates a 100% survival rate in animal models given lethal flu doses. With the resurgence of COVID-19 this flu season, FLUVID™ aims to fill a critical treatment gap for patients facing these concurrent illnesses. Developed from years of research, FLUVID™ targets multiple influenza strains alongside COVID-19.

Positive

• FLUVID™ therapy shows potential to treat both COVID-19 and influenza co-infections effectively.
• True Human antibodies in FLUVID™ neutralize COVID-19 at concentrations four times better than currently considered FDA antibodies.
• 100% survival rate in animal studies for those receiving lethal doses of flu viruses.

Negative

• None.

Candidate Therapy for Flu+Covid-19 Co-infection Shows Potent Anti-Viral Potential

AUSTIN, Texas, Nov. 19, 2020 (GLOBE NEWSWIRE) -- XBiotech Inc. (NASDAQ: XBIT) announced today new data for its breakthrough candidate therapy for treating infections of influenza and COVID-19. The Company continues to analyze components of its so-called FLUVID™ therapy as it develops manufacturing capability for a product candidate. The True Human antibodies targeting the virus causing COVID-19 were found to effectively neutralize a test virus at concentrations about four-times better than the antibodies the FDA is now considering for emergency use authorization. Ongoing research has also found that the True Human antibodies in this therapeutic cocktail that target influenza are capable of rescuing 100% of animals that receive an otherwise lethal dose of flu virus. The latest research findings suggest the FLUVID™ therapy, designed to be effective against all known strains of influenza in addition to the COVID-19 virus, could provide a uniquely effective therapy for treating complex infections from one or more of these viruses. There is no other therapy available to treat both COVID-19 and Influenza infections that occur together.

With the resurgence of the COVID-19 virus during this oncoming flu season, we are faced with the likelihood that many people will be infected by both influenza and COVID-19 viruses. Co-infections, or “superinfections”, may increase severity of disease and further complicate treatment. A therapy that could treat COVID-19+Influenza co-infections is urgently needed.

While the COVID-19 pandemic has only recently emerged, the FLUVID™ candidate therapy is the result of years of Research and Development at XBiotech, incorporating extraordinary influenza True Human antibodies that have been systematically evaluated for their ability to target virtually all known strains of influenza viruses. Whereas the True Human COVID-19 antibodies were derived from patients who recovered rapidly without serious illness and therefore should have potent neutralizing capability against the virus.

The influenza strains that will be targeted by FLUVID include: seasonal H1N1 and H3N2 strains; pandemic strains H1N1, H2N2, H3N2; avian influenza strains H5N1, H5N2 and H7N9; and even H9N2 and H10N8, which are currently in poultry but are believed to have pandemic potential in humans.

Dr. Sushma Shivaswamy, Ph.D., XBiotech’s Chief Scientific Officer, commented, “We continue to see outstanding data as we move this unique and critical therapy toward the clinic. Unlike any other Research and Development program, our pipeline is focused on delivering therapies to the vulnerable demographic that is most in need of the FLUVID™ therapy. We believe strongly in the potential of this product candidate.”

About XBiotech
XBiotech is a fully integrated, global biopharmaceutical company dedicated to pioneering the discovery, development and commercialization of therapeutic antibodies. XBiotech currently is advancing a pipeline of therapies based on harnessing naturally occurring antibodies from patients with immunity to certain diseases. The approach to use natural human immunity as a source of new medicines offers the potential to redefine the standards of care a wide range of diseases. Headquartered in Austin, Texas, XBiotech also is leading the development of innovative manufacturing technology to reduce the cost and complexity of biological drug production. For more information, visit www.xbiotech.com.

About True Human™ Therapeutic Antibodies
XBiotech’s True Human™ antibodies are the only available antibodies derived without modification from humans who possess natural immunity to certain diseases. (Unlike all commercially available antibodies, which are called “Humanized” or “Fully Human”, XBiotech’s True Human™ antibodies are directly sourced from the natural human immune response for specific diseases without modification, and thereby have not been shown to cause immunogenicity.) With discovery and clinical programs across multiple disease areas, XBiotech’s True Human antibodies have the potential to harness the body’s natural immunity to fight disease with increased safety, efficacy and tolerability.

Cautionary Note on Forward-Looking Statements
This press release contains forward-looking statements, including declarations regarding management's beliefs and expectations that involve substantial risks and uncertainties. In some cases, you can identify forward-looking statements by terminology such as "may," "will," "should," "would," "could," "expects," "plans," "contemplate," "anticipates," "believes," "estimates," "predicts," "projects," "intend" or "continue" or the negative of such terms or other comparable terminology, although not all forward-looking statements contain these identifying words. Forward-looking statements are subject to inherent risks and uncertainties in predicting future results and conditions that could cause the actual results to differ materially from those projected in these forward-looking statements. These risks and uncertainties are subject to the disclosures set forth in the "Risk Factors" section of certain of our SEC filings. Forward-looking statements are not guarantees of future performance, and our actual results of operations, financial condition and liquidity, and the development of the industry in which we operate, may differ materially from the forward-looking statements contained in this press release. Any forward-looking statements that we make in this press release speak only as of the date of this press release. We assume no obligation to update our forward-looking statements whether as a result of new information, future events or otherwise, after the date of this press release.

Contact
Ashley Otero
aotero@xbiotech.com
512-386-2930 

FAQ

What is the significance of XBIT's FLUVID™ therapy?

XBIT's FLUVID™ therapy aims to effectively treat co-infections of influenza and COVID-19, addressing a critical need during the ongoing pandemic.

How effective are the True Human antibodies in XBIT's FLUVID™ therapy?

The True Human antibodies in FLUVID™ can neutralize COVID-19 at concentrations four times better than those currently considered for FDA emergency use.

What are the survival rates observed in animal studies for FLUVID™ therapy?

Animal studies show a 100% survival rate for subjects treated with FLUVID™ after receiving lethal doses of influenza.

What influenza strains does XBIT's FLUVID™ therapy target?

FLUVID™ is designed to target several influenza strains, including seasonal and pandemic variants as well as avian influenza strains.